MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 HIGH PERFORMANCE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number	DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id:(b)(4).The digitaldiagnost 4.X is a stationary x-ray system for general radiographic purposes.For anatomies that are larger than the detector size, it is possible to make a series of exposures covering the whole anatomy (for example full spine or full legs).These individual images can be "stitched" together via the software program.For proper patient positioning and support, the patient can be placed on the so-called stitching patient support or stitching stand (9890 010 87432), a platform with two handles that the patient can hold on to during the examination.For the ease of use during transportation, the patient support for stitching has wheels and a folding footboard.The footboard is connected to the frame via two hinges and a brake cylinder.It has to be folded up and fixed by a hook for transportation, e.G.From one room to another.The brake cylinder was introduced with fco71200185 and has the task to ensure that the footboard lowers itself slowly (within 5-7 seconds) when the hook is released, to prevent the footplate from falling on the foot of a person.If the operator steps on the footboard while it is still moving down, the mounting of the brake cylinder can break and the footboard falls down immediately.In a worst case, it may hit the foot of a person and break a bone.Philips received a complaint on digitaldiagnost 4.X indicating that the patient support is broken.The use of the device was unknown and there was no harm to the patient or user.The field service engineer (fse) performed analysis and concluded that the patient support with a single gas spring was broken.Based on the fse's good faith effort response, there were no indications of misuse by the user; rather, the damage appeared to be the result of prolonged and frequent use over time.The fse replaced it with a new version that includes two gas springs on the stitching stand.After the replacement, the system was functioning properly.Based on the information available and the testing conducted, the cause of the reported problem was wear and tear.The reported problem was confirmed by the customer.
Event or Problem Description
It was reported that the patient support is broken.The use of the device was unknown and there was no harm to the patient or user.

• Brand Name: DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
• Common Device Name: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer Contact: dusty leppert ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 22042568
• Report Number: 3003768251-2025-000071
• Device Sequence Number: 12957124
• Product Code: MQB
• UDI-Device Identifier: 00884838065321
• UDI-Public: (01)00884838065321
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
• Device Catalogue Number: 712031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown